Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
- Conditions
- Peripheral Arterial Disease
- Interventions
- Biological: PlaceboBiological: Ixmyelocel-T
- Registration Number
- NCT00468000
- Lead Sponsor
- Vericel Corporation
- Brief Summary
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.
The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.
- Detailed Description
The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia.
Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs when peripheral arteries are damaged by arterial hypertension and/or by the formation of atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven PAD. These sequelae represent the end stage of PAD. PAD is associated with several other clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes, tobacco use, obesity and stroke.
The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular injections of the TRC product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Males and females, 18-90 years of age
- Diagnosis of CLI
- Infrainguinal occlusive disease, without options for revascularization
- No surgical interventions planned
- Life expectancy of 2 years
- Normal organ and marrow function
- Patients with controlled blood pressure (≤ 180/110 mmHg) and established anti-hypertensive therapy
- Established anti-platelet therapy
- Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 10%)
- Aortoiliac disease with > 50% stenosis
- Wounds with severity greater than Grade 3 on the Wagner Scale
- Any known failed ipsilateral revascularization within 2 weeks of enrollment
- Previous amputation of the talus, or above in the target limb
- Life-threatening ventricular arrhythmia; unstable angina; or, myocardial infarction within 4 weeks of enrollment
- Severe congestive heart failure (CHF) (i.e. New York Heart Association [NYHA] Stage IV)
- Receiving treatment with hematopoietic growth factors
- Infection of the involved extremity(ies)
- Active wet gangrenous tissue
- Require uninterruptible anticoagulation therapy
- Blood clotting disorder
- Cancer
- End stage renal disease requiring dialysis for more than 6 months prior to enrollment
- Pregnant or lactating
- Having received medication for thrombolytic therapy (e.g. rTPA or other enzymatic clot busters) within 30 days prior to enrollment
- Undergoing hyperbaric oxygen treatment within 2 weeks of enrollment
- Concomitant wound treatments with growth factors or tissue engineered products
- Receiving anti-angiogenic drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo The control arm of the study will receive placebo injections. Ixmyelocel-T Ixmyelocel-T The treatment arm of the study will receive injections of the study cellular product.
- Primary Outcome Measures
Name Time Method Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale) throughout trial
- Secondary Outcome Measures
Name Time Method Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene) Day 7 and Months 3, 6, 9, 12 Percentage of patients failing treatment Day 7, and Months 3,6,9, and 12 Incidence of bypass surgery for patients throughout duration of study Day 7 and Months 3,6,9,12 Healing of all wounds in the target limb Day 7 and Months 3,6,9,12 The King's College Vascular Quality of Life Questionnaire Baseline and Months 6 and 12 Walking distance as measured by six-minute walk test(with or without walking device) Baseline and Month 12 Time to major amputation Day 7 and Month 3, 6, 9, and 12 Percentage of patients undergoing major amputation Day 7 and Months 3, 6, 9, 12 Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index Day 7 and Months 3,6,9,12 Concurrent Meds for trends Day 7 and Months 3, 6, 9, 12 Incidence of revascularization interventions throughout duration of study Day 7 and Months 3,6,9,12 Pain, as measured by visual analog scale(VAS) Day 7 and Months 3,6,9,12
Trial Locations
- Locations (20)
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Jobst Vascular Center
🇺🇸Toledo, Ohio, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
University of Miami/Miller School of Medicine
🇺🇸Miami, Florida, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Peripheral Vascular Associates
🇺🇸San Antonio, Texas, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Memorial Center
🇺🇸Lebanon, New Hampshire, United States
Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System
🇺🇸Gainesville, Florida, United States
Loyola University Stritch School of Medicine
🇺🇸Maywood, Illinois, United States
The Care Group, LLC
🇺🇸Indianapolis, Indiana, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Michigan Vascular Research Center
🇺🇸Flint, Michigan, United States
Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States
Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
VA Ann Arbor Healthcare System
🇺🇸Ann Arbor, Michigan, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Oklahoma University
🇺🇸Oklahoma City, Oklahoma, United States